1. Field of the Invention
The present invention relates to prosthetics. More particularly, the present invention relates to a novel process for constructing a prosthetic limb through a series of fabrication steps including retrieving a file from a computer, manipulating that file that has captured alignment and socket fit, then having to adjust each “Z” line in the file to insure the strongest build of the socket with proper trim lines, sending it to a 3D printer, which in turn has the ability to print out a completed, wearable prosthetic limb constructed of a material, preferably Nylon 12, but other suitable materials may include ULTEM®, strong plastic material, such as ULTEM® (A Registered Trademark of General Electric Co.), carbon fiber, or other material of equal or greater strength that may be known or developed in the future; and which provides that the inner and outer surfaces of the prosthetic socket undergo a process to smooth and seal the surfaces to improve the wearability.
2. General Background of the Invention
The design of an effective prosthetic socket is crucial to the rehabilitation and overall health of a person with an amputated limb. Most of the time and energy a practitioner applies in making a prosthesis is spent on fabricating the socket that must be fitted to the residual limb. The prosthetic socket must be shaped so that it supports the residual limb in load tolerant areas, while avoiding irritation of sensitive regions on the limb that contact the inner surface of the socket. If these criteria are not achieved, when the patient uses the prosthesis, residual limb soft tissue breakdown often occurs. The result is painful sores, blisters, ulcers, or cysts on the residual limb that typically restrict continued prosthesis use, and in severe cases, necessitate a further amputation to a higher anatomical level, which can lead to further disability. The incidence of skin breakdown in lower-limb amputees has been reported to be from 24% to 41%. Accordingly, at any one time, as many as 41% of prosthesis users may be experiencing breakdown of the tissue on the residual limb. The principal cause of such breakdown is a poorly fitting prosthetic socket.
Practitioners face challenges in making quality sockets for the increasing amputee popularity. Also, there is a shortage of prosthetists in the industry, and that shortage is expected to increase in the future, as the demand for prosthetic devices increases. A prosthetist's time is precious and must be used as efficiently as possible. It will therefore be evident that there is a need for technology to improve a prosthetist's efficiency, speed, documentation, repeatability, and quality of fitting a socket to a patient's residual limb, and to ensure a proper socket design early in the process of fitting a prosthetic socket to a recipient.
In the current state of the art, one way of capturing an image of a residual limb in order to gather a positive mold is by hand casting. The procedure one would use in the traditional format of hand casting would follow certain steps. The initial step would include the following materials and tools needed for measuring the patient: stockinette, plaster bandages, indelible pencil, preparations for suspension (example: silicone liners, foam liners, hard socket), also measuring tools such as a length stick M/L gauge and tape measure. These tools and materials would assist a prosthetist in taking the proper cast along with techniques they acquired through training.
After the proper cast has been taken by a certified individual, the fabrication of the test socket would be as follows. First, one would pour the negative mold or cast in order to receive the positive mold with a powder substance called plaster of paris. Once the plaster hardens, the next step is striping the plaster bandages off of the mold. Then the positive mold is modified by hand to achieve its voids and pressure points in precise locations with plaster of paris. After the desired reliefs are added it is then ready for a term used in the industry known as either drap pull or bubble pull. These are techniques in which a clear plastic is pulled over the positive model. Therefore, this manual technique for capturing an image of a residual limb in order to gather a positive mold is greatly improved upon by the use of a digital process as will be described herein.
The following U.S. patents are incorporated herein by reference:
Pat. No.TitleIssue Date7,447,558Apparatus for Determining A ThreeNov. 4, 2008Dimensional Shape of an Obiect7,225,050Method and Apparatus for Precisely Fitting,May 29, 2007Reproducing, and Creating 3-DimensionalObjects from Digitized and/or ParametricData Inputs Using Computer Aided Designand Manufacturing Technology7,162,322Custom Prosthetic Liner ManufacturingJan. 9, 2007System and Method6,463,351Method for Producing Custom FittedOct. 8, 2002Medical Devices2010/Orthotic or Prosthetic Cushioned Device andJun. 24, 20100161076Method of Making the Same2010/Computer Aided Design and ManufacturingJan. 28, 20100023149of Transtibial Prosthetic Sockets2006/Method and Associated System forJan. 26, 20060020348Recording and Retrieving Fabrication and/orFitting Data Associated with a ProstheticComponent2006/Computer-Aided-Design of SkeletalMay 4, 20060094951Implants